Prolonged dose-dense epirubicin and cyclophosphamide followed by paclitaxel in breast cancer is feasible.
OBJECTIVE
We conducted a pilot study of dose-dense epirubicin/cyclophosphamide (EC) x 6 --> paclitaxel (P) x 6 with pegfilgrastim. A previous dose-dense trial of FEC (5-fluorouracil [5-FU]/EC) x 6 with filgrastim --> by weekly paclitaxel alternating with docetaxel x 18 was not feasible because of pneumonitis (with dose-dense FEC) and pericardial/pleural effusion (taxane phase). Dose-dense EC (without the 5-FU) is not associated with pneumonitis, and dose-dense paclitaxel (alone) is feasible. Primary objective was feasibility.


METHODS
Patients with resectable breast cancer were enrolled, regardless of surgery status, tumor size, or nodal status. Treatment regimen consisted of every-2-week EC (100/600 mg/m2) x 6 --> by 2-weekly P (175 mg/m2) x 6 with pegfilgrastim 6 mg on day 2.


RESULTS
Between November 2004 and May 2005, 38 patients were enrolled. The median age was 47 years (range, 30-72 years); 33 of 38 (87%) were treated in the adjuvant setting and 27 of 33 (81%) had involved nodes (range, 1-46); 5 of 38 (13%) were treated pre-operatively; 33 of 38 (87%) completed all chemotherapy as planned; the remaining patients (13%) had treatment modifications for toxicity. Febrile neutropenia occurred in 6 of 38 patients (16 %) and only during EC. There were 12 hospitalizations in 9 of 38 patients (24%) enrolled.


CONCLUSIONS
Dose-dense every-2-week EC x 6 --> P x 6 with pegfilgrastim is feasible based on our prospective definition.
Dang
Chau
C
Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY 10021, USA. dangc@mskcc.org
D'Andrea
Gabriella
G
Lake
Diana
D
Sugarman
Steve
S
Fornier
Monica
M
Moynahan
Mary Ellen
ME
Gilewski
Theresa
T
Hurria
Arti
A
Mills
Nancy
N
Troso-Sandoval
Tiffany
T
George
Roshini
R
Robson
Mark
M
Dickler
Maura
M
Smith
Karen
K
Panageas
Katherine S
KS
Norton
Larry
L
Hudis
Clifford A
CA
D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D001943:Breast Neoplasms / Q000188:drug therapy*; D003520:Cyclophosphamide / Q000008:administration & dosage / Q000009:adverse effects; D015251:Epirubicin / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D006801:Humans; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D010865:Pilot Projects
D015251:Epirubicin; D003520:Cyclophosphamide; D017239:Paclitaxel